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Tyrosine Kinase Inhibitor

Pazopanib for Carcinoid Tumor

Phase 2

Waitlist Available

Led By Emily K Bergsland

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior treatment with an inhibitor of VEGF or VEGFR

Age >= 18 years

Must not have

Symptomatic peripheral vascular disease

INR > 1.2 X ULN for patients receiving anticoagulant therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing how well pazopanib hydrochloride works in treating patients with carcinoid tumors. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?

Adults with low or intermediate-grade neuroendocrine carcinoid tumors that can't be surgically removed or have spread, and show signs of progression. Participants must not have high-grade variants, significant recent cardiovascular issues, uncontrolled blood pressure, bleeding risks, immune compromise conditions, or certain gastrointestinal problems. Pregnant women and those on strong CYP3A4 inhibitors are excluded.

What is being tested?

The trial is testing the effectiveness of Pazopanib Hydrochloride in slowing down or stopping tumor growth compared to a placebo. It's randomized and includes various assessments like echocardiography and MRI to monitor heart function and tumor changes.

What are the potential side effects?

Pazopanib may cause liver issues (elevated liver enzymes), heart problems (high blood pressure, decreased heart function), risk of bleeding events (hemorrhage), fatigue, diarrhea, nausea, hair color change, loss of appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never been treated with drugs that target VEGF or VEGFR.

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I am 18 years old or older.

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I have a confirmed carcinoid tumor.

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My cancer can be measured by scans and is at least 1 cm in size.

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My cancer is a low or intermediate-grade neuroendocrine type, not high-grade or poorly differentiated.

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My cancer has worsened in the last year, even with treatment.

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My cancer cannot be removed by surgery and may have spread.

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I have not had heart failure symptoms in the last 6 months.

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I do not have irregular heartbeats or prolonged QTc.

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My cancer is a low- or intermediate-grade neuroendocrine type.

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My blood clotting test results are within the normal range, even though I'm on blood thinners.

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My cancer has not spread to my brain or spinal cord.

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I do not have unstable heart pain or uncontrolled irregular heartbeats.

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I haven't had serious stomach or intestine problems in the last month.

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I am not pregnant.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have symptoms of poor blood flow in my limbs.

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My blood clotting time is slightly higher due to my anticoagulant medication.

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My lung cancer affects the airways or blood vessels in my lungs.

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I haven't had serious wounds, ulcers, injuries, or broken bones in the last 28 days.

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I have had a condition where my lymphocytes grow abnormally.

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My cancer has spread to the large blood vessels of my lungs.

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I have large growths in the main airways of my lungs.

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I have a condition that weakens my immune system.

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I am not on any strong CYP3A4 inhibitors.

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I do not have unstable heart pain or uncontrolled irregular heartbeats.

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I have a history of cancer.

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My cancer is a specific type of aggressive neuroendocrine tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS)

Secondary study objectives

Best Response

Duration of Response for the Subset of Patients With a Confirmed Complete Response or Partial Response

Overall Survival

+1 more

Other study objectives

Biochemical Response

PFS Within Each Arm

Side effects data

From 2016 Phase 2 trial • 22 Patients • NCT01247571

79%

Nausea

74%

Fatigue

68%

Diarrhea

53%

Neutrophil Count Decreased

53%

White Blood Cell Decreased

53%

Hypertension

47%

Anemia

42%

Vomiting

42%

Peripheral Sensory Neuropathy

37%

Constipation

37%

Abdominal Pain

32%

Anorexia

32%

Headache

32%

Dyspnea

26%

Cough

21%

Weight Loss

21%

Alopecia

21%

Alanine Aminotransferase Increased

21%

Hyponatremia

21%

Hypoalbuminemia

21%

Pain In Extremity

21%

Depression

21%

Aspartate Aminotransferase Increased

16%

Blurred Vision

16%

Dysphagia

16%

Blood Bilirubin Increased

16%

Dry Mouth

16%

Alkaline Phosphatase Increased

16%

Hypomagnesemia

16%

Hypocalcemia

16%

Arthralgia

16%

Memory Impairment

16%

Insomnia

16%

Epistaxis

11%

Platelet Count Decreased

11%

Tinnitus

11%

Hearing Impaired

11%

Creatinine Increased

11%

Rectal Hemorrhage

11%

Gastroesophageal Reflux Disease

11%

Hypokalemia

11%

Hypoglycemia

11%

Hyperglycemia

11%

Neck Pain

11%

Generalized Muscle Weakness

11%

Dizziness

11%

Anxiety

11%

Vaginal Hemorrhage

11%

Vaginal Discharge

11%

Rash Maculo-Papular

11%

Skin Hypopigmentation

11%

Urinary Frequency

Lymphocyte Count Decreased

Sinus Tachycardia

Ear Pain

Dyspepsia

Proctitis

Ascites

Death Nos

Sinus Bradycardia

Sepsis

Urinary Tract Infection

Bruising

Investigations - Other

Mucositis Oral

Pain

Oral Pain

Edema Trunk

Flatulence

Fever

Gastrointestinal Pain

Bloating

Edema Limbs

Sinusitis

Reproductive System And Breast Disorders - Other

Dehydration

Back Pain

Arthritis

Paresthesia

Dysgeusia

Urinary Retention

Pelvic Pain

Allergic Rhinitis

Skin And Subcutaneous Tissue Disorders - Other

Nail Discoloration

Dry Skin

Proteinuria

100%

80%

60%

40%

20%

Study treatment Arm

Pazopanib

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (pazopanib hydrochloride)Experimental Treatment9 Interventions

Patients receive pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, MRI, and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study.

Group II: Arm II (placebo)Placebo Group9 Interventions

Patients receive placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, MRI, and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Multigated Acquisition Scan

2015

Completed Phase 3

~270